How Automatic Inspection Machines Support GMP & FDA Compliance

To satisfy these requirements, Inspection is essential in supporting the quality standards that define all products released to the public. The increasing level of regulatory oversight and the increasing speed at which products are being manufactured have caused many companies to move away from manual inspections and toward automatic inspection machines in order to better comply with regulatory requirements.

Automatic inspection machines play a critical role in supporting both GMP and FDA regulatory compliance. Automatic inspection machines support Regulatory Compliance through several aspects, including Quality Assurance, Documentation, Validation, and Long Term Regulatory Readiness, an approach similar to that of Accura Pharmaquip’s inspection philosophy.

Regulatory Overview: GMP & FDA Requirements for Inspection

Good Manufacturing Practice (GMP) Basics

GMP is focused on the assurance that pharmaceutical products are manufactured and controlled in a consistent and reproducible manner to ensure the quality standard. The manufacturing of solid dosage forms will require strict control of all aspects of product quality, potential for contamination, and consistency.

Therefore, key expectations from GMP regarding inspections include:

• Identifying defects through in-process and final inspections prior to product release
• Ensuring consistent quality across batch production
• Documenting and providing traceability for each critical quality process

Consequently, inspection systems should be reliable, repeatable and documented so as to ensure GMP compliance both at audit and at operational levels.

FDA Expectations for Solid Dosage Inspection

Strong Visual Inspection is emphasized by the FDA for Tablet & Capsule products to prevent defects in both the form & function of products from potentially impacting safety and efficacy. Some of the common defects that can cause problems with both the functionality and the form of these products are: Cracks, Chips, Discolourations, Foreign Matter and Dimensional Irregularities.

FDA Expectations generally follow a Risk-Based Approach in their assessment of the product’s defect detection capability as it pertains to patient safety. To meet the FDA expectations of inspection processes for detecting the most at-risk defects to the patient, clear rejection criteria, validation of the inspection process, and thorough documentation of the inspection process will be necessary.

Limitations of Manual Inspection in Regulatory Compliance

Although manual inspection has historically been used in the production of pharmaceuticals, there are many problems with using it as an inspection method in a regulated environment.

Manual inspections by humans are subject to such factors as:

• Operator fatigue and focus, which can diminish as hours of operation increase
• Operator subjectivity (i.e., variation among operators)
• Some variation in inspection results due to differences between operators

In addition, manual inspections produce limited documentation. Typically, audit trail records are insufficient; therefore, it is generally difficult to recreate the details of an inspection decision during a regulatory audit. These limitations create significant barriers for manufacturers to continue relying solely on manual inspections to comply with today’s GMP and FDA requirements.

Role of Automatic Inspection Machines in GMP Compliance

Consistent and Repeatable Inspection

Automatic Inspection Machines use standardized inspection protocols for each and every product inspected; thus providing consistency among all products regardless of batch or shift in which they were manufactured. Once a machine’s operating parameters have been validated, they will be changed only by a formal update to the controlled procedures governing that particular process.

The key GMP advantages include:

• Eliminating Operator Bias
• Providing uniformity of inspection results
• Allowing for 100% inspection capabilities versus random sampling

Consistency is required for continued GMP compliance.

Detection of Critical Quality Defects

Automatic inspection machines are designed to identify a large number of different quality defects, such as:

• Surface defects (cracks, chips, stains, discoloration),
• Contamination (foreign bodies)
• Dimensional or geometric irregularities

Early identification of these defects allows manufacturers to limit their exposure to defective products being used on patients.

Controlled and Validated Inspection Process

Inspection machines function under a controlled environment by utilizing:

• Predefined, validated inspection parameters
• Locked recipes to prevent any unauthorized adjustments
• User-access controls and role-based permissions

Change-management procedures and version-control mechanisms provide assurance that any modifications will be documented, reviewed, and approved as per GMP regulations.

How Automatic Inspection Machines Support FDA Compliance

Validation (IQ, OQ, PQ)

Validation is a very important component for all companies seeking to be compliant with the FDA, and automated inspection systems are directly involved in the validation process.

• IQ (Installation Qualification) – Validates that the Inspection Machine has been installed correctly according to the manufacturer’s specifications
• OQ (Operational Qualification) – Validates that the Inspection System will function properly as designed over all intended operating parameters
• PQ (Performance Qualification) – Validates that the Inspection Machine consistently performs during actual production and manufacturing operations

Automated inspection systems are able to generate quantifiable and reproducible results which make the validation process and the creation of required regulatory documentation much easier to complete.

21 CFR Part 11 & Data Integrity

The above information on how modern inspection systems support e-Data Integrity requirements (electronic) includes:

• Authentication of all electronic records
• Audit trail for a detailed history of all actions taken on those records
• Electronic signature of users who make changes to those records
• Security of user access levels & passwords for protection of those records

All the attributes listed above support both 21 CFR Part 11 and ALCOA+ principles by ensuring that the data generated is attributable, legible, contemporaneous, original and accurate.

Risk Mitigation and Recall Prevention

The early and correct identification of defects will reduce the possibility that a batch fails or is recalled. Automated inspection equipment builds confidence for product release decisions by giving manufacturers an opportunity to minimize their risk exposure from both regulatory and commercial perspectives.

Documentation and Traceability Benefits

Automated inspection equipment provides companies with substantial documentation, such as:

• Automatic inspection report generation
• Storage of images of products that have been rejected
• Logs of defective parts and statistical summaries
• Batch-wise traceability

The data generated from automated inspection equipment provides auditors with a rapid response and a more defined explanation when they conduct a regulatory audit; it also enhances compliance evidence.

Integration with Quality Systems

Inspectors may use modern inspection technology to collect data and provide feedback in real time to manufacturing staff who are operating their equipment.

Benefits of using a Quality Data System include:

• Centralized reporting of inspection results from MES or SCADA
• Achieving real-time quality monitoring
• Using data collected by inspectors as a means to improve process efficiency
• Data analysis is used to identify the root cause of failure

Quality systems use data from inspections to make informed decisions.

Common Compliance Challenges and How Machines Address Them

Compliance is a challenge for manufacturers due to ongoing issues that include:

• Highly inaccurate or false “reject” rates in compliance testing that can be reduced with software optimization and the fine-tuning of parameters.
• A changing set of regulatory requirements, which may be met by means of easily implemented changes to the software.
• Complexity in validation processes, which can be made easier by support from vendors in the form of documentation and protocols.

The design of automatic inspection machines will provide the opportunity for manufacturers to meet evolving compliance challenges.

Future of Compliance: Smart Inspection Systems

As we move into the future, pharmaceutical compliance will increasingly rely on smarter systems with increased connections between them. Some of the key emerging trends are:

• AI-aided defect classification
• Predictive quality analytics
• The development of Pharma 4.0 and ongoing compliance models
• Adaptive inspection systems that can react immediately to any changes in processes

These new technologies will continue to build upon the current status of automatic inspections to enable compliance.

Conclusion: Automatic Inspection as a Compliance Enabler

Automatic inspection systems are a critical component of supporting GMP and FDA compliance in Solid Dosage production. Automatic inspection systems support manufacturers in meeting regulatory expectations by providing consistent inspections, robust documentation, validated performance, and complete and accurate data integrity.

While some may view inspection machines as a cost, inspection machines should be viewed as a long-term quality investment for manufacturers and their Quality Assurance Teams. The message is clear: Automatic Inspection is not just a tool for detecting defects, but it is an investment in developing a compliant, reliable, and future-ready Quality System that aligns with Accura Pharmaquip‘s commitment to pharmaceutical excellence.